CompletedNot Applicable

The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence

Spain42 participantsStarted 2023-01-09

Plain-language summary

The following clinical trial investigates the efficacy of transvaginal radiofrequency in the physiotherapy treatment of stress urinary incontinence (SUI). The treatment compares transvaginal radiofrequency with pelvic floor muscle training (PFMT) and PFMT alone. The present study is a randomized controlled trial with double blinding (evaluator and patients). The objective is to evaluate what radiofrequency can provide in the improving of the quality of life, symptoms and pelvic floor muscle strength of patients with SUI. The reason for the combination with PFMT, is that it is the golden standard treatment in pelvic floor rehabilitation and SUI improvement.

Who can participate

Age range

20 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women between 20 - 75 years * Previously diagnosed SUI through assessment and questionnaires. * PAD Test of 1h with \> or = 1gr of urine loss. * Urine losses in the last week. * Nulliparous and multiparous. Exclusion Criteria: * Women \> 75 years. * Another type of urinary incontinence, urge or mixed. * Difficulty urinating * Hematuria * Pregnancy * Patients with any type of cancer or with a personal history of it. * Previous surgeries for the treatment of SUI * Gynecological surgeries (hysterectomy, containment mesh for different prolapses). * Neurological and cognitive problems. * Injury to the spinal cord, lower limbs or pelvis. * Grade II, III or IV pelvic organ prolapse. * Vaginal or urinary infection. * Drugs: * Antimuscarinics (oxybutinin) * Toterodine * Trospium * Solifenacin * Darifenacin * Fesoterodine * Atropine * Anticholinergics * Antidepressants: * Duloxetine * Imipramine * Estrogens * Botulinum Toxin * Alpha-adrenergic agonists * Ephedrine * Pseudoephedrine * Antidiuretics (desmopressin)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in the ICIQ-SF scale before, after and six months after treatment in both groups.

Timeframe: Before treatment, six weeks of treatment, and 6 months assessments were required.

The change of signs, symptoms and impact of pelvic floor dysfunction (PFDI-20) between reviews (before, after and at six months of treatment in both groups).

Timeframe: Before treatment, six weeks of treatment, and 6 months assessments were required.

The change of signs, symptoms and impact of pelvic floor dysfunction (PFIQ-7) between reviews (before, after and at six months of treatment in both groups)

Timeframe: Before treatment, six weeks of treatment, and 6 months assessments were required.

Trial details

NCT IDNCT05702567

SponsorJosé Casaña Granell

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-27

View on ClinicalTrials.gov More Urinary Incontinence,Stress trials

Plain-language summary

Who can participate

Age range

20 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in the ICIQ-SF scale before, after and six months after treatment in both groups.

Timeframe: Before treatment, six weeks of treatment, and 6 months assessments were required.

The change of signs, symptoms and impact of pelvic floor dysfunction (PFDI-20) between reviews (before, after and at six months of treatment in both groups).

Timeframe: Before treatment, six weeks of treatment, and 6 months assessments were required.

The change of signs, symptoms and impact of pelvic floor dysfunction (PFIQ-7) between reviews (before, after and at six months of treatment in both groups)

Timeframe: Before treatment, six weeks of treatment, and 6 months assessments were required.